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HPLC-CAD法测定健儿消食口服液中黄芪甲苷的含量

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目的:建立高效液相色谱-电喷雾检测器法(HPLC-CAD)测定黄芪甲苷的含量,从而改进现行标准含量测定方法。方法:采用ZORBAX SB-C8 Agilent液相色谱柱(4。6 mm ×250 mm,5μm),乙腈-水(35∶65)为流动相,梯度洗脱,流速1 mL·min-1,柱温室温,理论板数≥4 000;电喷雾检测器检测参数:控制模式remote(N2000,1∶local0),雾化管温25℃,载气(氮气)流速:4 L·min-1。通过方法学考察,确认该色谱条件下黄芪甲苷含量测定方法的可行性和可靠性。结果:黄芪甲苷在2。25~101。68 μg·mL-1浓度范围内呈良好的线性关系,重复性试验含量测定平均值为0。824 mg·mL-1,RSD=1。35%;平均回收率为99。2%,RSD 1。2%;10批样品的平均含量为0。81 8 mg·mL-1,RSD为1。8%。结论:经方法学验证,本法可作为健儿消食口服液质量控制的方法。
Determination of astragaloside Ⅳ in Jianer Xiaoshi oral liquid by HPLC-CAD
Objective:To establish an HPLC-CAD method to determine the content of astragaloside in Jianer Xiaoshi oral liquid in order to improve the content determination method in the current standard.Methods:Agilent ZORBAX SB-C8 column(4.6 mm ×250 mm,5 μm)was adopted with acetonitrile-water(35∶65)as the mobile phaseat the flow rate of 1 mL·min-1 by gradient elution.Column temperature was room temperature,and theoretical plate number was ≥4 000.Detection parameters of electrospray detector:control mode remote(N2000,1∶local0),atomizing tube temperature 25 ℃,carrier gas(nitrogen)was at flow rate:4 L·min-1.The feasibility and relia-bility of this method for the determination of astragaloside were confirmed by various methods.Results:The method showed a good linear relationship in the concentration range of 2.25-101.68 μg·mL-1.RSD of content was 1.35%in repeatability test with average content of 0.824 mg·mL-1:The average recovery rate(n=3)was 99.2%with RSD 1.2%,which met the requirements.Conclusion:The method verified by methodology can be applied quality control of Jianer Xiaoshi oral liquid method.

Jianer Xiaoshi oral liquidastragalosideHPLC-CADcontent determinationverifyimprovement

赵春荷

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西峡县产品质量检验检测中心,河南西峡 474500

健儿消食口服液 黄芪甲苷 HPLC-CAD 含量测定 验证 提升

2024

中国药品标准
国家药典委员会

中国药品标准

影响因子:0.372
ISSN:1009-3656
年,卷(期):2024.25(1)
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